510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K884018Substantially Equivalent

Lamelli Oxygen Enriched Environment System & Tent

Lamelli Pulmonary Research Center, Ontario CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884018 is the FDA 510(k) clearance record for LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT, a class II device, cleared for Lamelli Pulmonary Research Center on under FDA product code CAW (Generator, Oxygen, Portable). FDA records list one 510(k) clearance for Lamelli Pulmonary Research Center. As of , FDA records show no recalls naming K884018.

Clearance record

Decision date
Received
(158 days to decision)
Product code
CAW Generator, Oxygen, Portable
Regulation
21 CFR 868.5440
Device class
Class II
Review panel
Anesthesiology
Applicant
Lamelli Pulmonary Research Center 320 W. Walnut Ave. #24, Ontario CA
Third party review
No

Clearances, product code CAW

Trailing 12 months
12 clearances under product code CAW in the twelve months to October 2026, December 2025 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code CAW, trailing twelve months
MonthClearances
November 20251
December 20255
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20261
September 20261
October 20260